trial of folf(ha)iri with cetuximab in mcrc

Conditions: Metastatic Colorectal Cancer

Summary: as an approach to improve efficacy and provide clinical benefit to cancer patients undergoing chemotherapeutic treatment regimens, alchemia oncology has developed a novel means for delivering anti-cancer agents to tumours. the drug delivery platform is based on the use of hyaluronic acid (ha), a novel excipient, in which, formulation with ha results in optimisation of cytotoxic drug uptake and retention within solid tumours. in the specific example of ha-irinotecan, this new formulation of irinotecan has demonstrated enhanced efficacy in both nonclinical and early clinical studies. the current study is an investigation into the use of ha-irinotecan in a phase ii single arm trial of folf(ha)iri plus cetuximab in irinotecan-naïve second line patients with kras wild type metastatic colorectal cancer. the study objectives are to confirm the safety and efficacy of folf(ha)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic colorectal cancer patients. it is expected that the study recruit approximately 40-50 patients in 1 year with subsequent treatment and follow up; thus the trial will run for approximately 2-3 years.


Eligibility criteria:
inclusion criteria * tumour is kras wild type * mcrc with disease progression after first-line chemotherapy (adjuvant chemotherapy is considered first line chemotherapy if metastatic progression occurs within 6 months of the end of the adjuvant chemotherapy). * irinotecan naïve * prior use of bevacizumab in the 1st line setting is permitted. * ecog 0 or 1 * measurable disease * histological proof of colorectal adenocarcinoma * 18+ years of age * adequately recovered from and at least 4 weeks after recent major surgery or chemotherapy * at least 4 weeks after treatment with a biologic monotherapy from last dose to enrolment. * hematology done within 14 days prior to enrolment : * absolute neutrophil count (anc) greater than 1.5 x 109/l * platelets greater than 100 x 109/l * hemoglobin greater than or equal to 100g/l * chemistry done within 14 days prior to enrolment: * ast greater than or equal to 2.5 x uln (greater than 5 x uln if elevation thought to be related to hepatic metastatic disease), * alkaline phosphatase greater than 5 x uln, * serum creatinine greater than 1.5 x uln, * total bilirubin greater than 34.2 µmol/l, * negative serum or urine pregnancy test if a wocbp. exclusion criteria * kras mutant. * prior irinotecan * prior anti-egfr * history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 5 years. * locally advanced or recurrent disease only * unsuitability for irinotecan * abdominal or pelvic radiation therapy (including treatment with sir-spheres/sirtex) within the last 12 months. * women who are pregnant or breastfeeding. * significant cardiac disease * untreated or symptomatic brain or central nervous system (cns) metastases * presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis. * current partial or complete bowel obstruction. * concomitant active infection.

Keywords: mcrc colorectal cancer